Regulatory Affairs Leader Jobs

Summary
As a Regulatory Affairs Leader, you will lead and maintain regulatory strategies for Standalone Software Devices including PACS medical devices. You will provide inputs and highlights to the leadership regarding upcoming regulatory changes. You will drive regulatory approvals in emerging countries, approve marketing communications and work closely with regulatory, engineering, marketing, legal and other professionals across the organization to establish and maintain regulatory compliance. You will also assist and provide guidance with post market surveillance activities.At GE HealthCare, our machines, our software, our solutions, our services, and our people make a genuine difference to medical professionals and patients all over the world. That’s because we never lose sight of what healthcare really needs—the human touch.
Roles and Responsibilities:

• Assesses changes in existing products and determines the need for new / revised licenses or registrations.
• Provides regulatory strategy and direction to the PACS (Software as a Medical Device - SaMD) business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally.
• Prepares global regulatory submissions by working across the regulatory organization and cross functionally with other functions such as Engineering, Clinical, and Scientific, and submits premarket submissions to regulatory authorities such as FDA, NMPA, EU, etc., as per business’ timelines.
• Communicate with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations.
• Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.

Required Qualifications:

• Professional experience in Regulatory Affairs / Quality Assurance.
• Bachelor's degree in a Scientific, Engineering, Computer Science, core Life Science discipline, or a combination of training and experience demonstrating the equivalent.
• Proved work experience in heavily regulated fields such as medical devices, pharmaceuticals, or biologics.
• Professional experience in regulatory project management/program management and regulatory agency interactions.

Desired Characteristics:

• Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial, or political situations and their impact on GE HealthCare regulatory strategies.
• Experience with Software as a Medical Device (SaMD), cybersecurity, and other non-device software products.
• Demonstrated life-long learner; eagerness to obtain new skills and knowledge.

We expect all employees to live and breathe our behaviors, to act with humility and build trust, lead with transparency, deliver with focus, and drive ownership - always unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Additional Information
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
Relocation Assistance Provided: No